Process & Development Lab

The mission of the Process and Development Laboratory of PGTC (PD) is to develop methods for large-scale manufacturing of rAAV stocks in a GMP-translatable manner. The methods currently utilized in this group is the HSV coinfection method and the PEI co-transfection protocol, both using suspension cells grown in shaker flasks or single use bio-reactors.

Quality Control Lab

The Quality Control Laboratory is responsible to perform or review all the testing required for GLP and GMP-grade rAAV stocks at GLP or GMP-level. The QC laboratory also assists with sample analysis of PD test runs. The PD and QC labs are also responsible for the production and release testing of all GLP grade stocks of Test Articles for IND-enabling studies using GMP-like protocols.

Personnel

Nathalie Clement

Nathalie Clément, Ph.D.

Associate Director, PGTC
Director PD/QC Lab

Dr. Clément as Associate Director is in charge of the PD/QC for the PGTC, located in the Department of Pediatrics, Powell Gene Therapy Center. More particularly she is involved in Process & Development of new methods for large-scale AAV vector production and purification. These activities are performed in tight collaboration with the Vector Core and the Human Application Laboratory to ensure efficient and swift transfer of these methodologies to GMP settings for clinical grade preparations.

Additional Personnel

  • Radhika Bhake
  • Tina Caton
  • Payel Chaudhuri
  • Evan Johnson
  • Eugene Krasnogorskyi
  • Prasad Trivedi